Uterine Manipulator

ABSTRACT

A uterine manipulator device includes: an elongated cannulated tube comprising a proximal end and a distal end; a cervical cup having a top proximal portion of a first diameter and a base distal portion of a second smaller diameter, wherein: the base distal portion includes a hole formed therein having a perimeter including a distal end and a proximal end, and including a longitudinal axis positioned therethrough; one of the proximal end of the perimeter and the distal end of the perimeter is angled away from the longitudinal axis and the other of the proximal end of the perimeter and the distal end of the perimeter is in line with the longitudinal axis; and the elongated cannulated tube is positioned through the hole in the cervical cup.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 17/198,506 filed Mar. 11, 2021 which is acontinuation of U.S. Non-Provisional patent application Ser. No.15/617,299 filed on Jun. 8, 2017 (now U.S. Pat. No. 11,278,322), whichclaims priority to and the benefit of U.S. Provisional PatentApplication No. 62/347,781, filed on Jun. 9, 2016, the entire contentsof which are hereby incorporated by reference.

FIELD OF THE INVENTION

The present disclosure relates generally to devices and methods formanipulation of the uterus and cervix in surgical and diagnosticprocedures.

BACKGROUND

Various conventional forms of uterine manipulators and vaginal cervicalretractors are known. For example, U.S. Pat. No. 5,209,754 describes avaginal cervical retractor generally consisting of a proximal (to thepatient) half-length curved outer shaft (corresponding to the curve ofthe posterior pelvis) and a straight distal half connected to a handle,an inner cap positioned within an outer cap and a circular disc locatedat the proximal end of the outer tube, and an inner plastic tubepositioned through the outer tube and the circular disc, inner cap andouter cap (which can include one cervical cup in certain conventionaldevices) with a balloon on the proximal end. The vaginal cervicalretractor is used to maneuver and visualize the uterus during variousmedical examinations and laparoscopic procedures while maintainingpneumoperitoneum. Such examinations and procedures include a complete,total laparoscopic hysterectomy, a partial laparoscopic hysterectomy,and a colpotomy. While the vaginal cervical retractor maneuvers theuterus during a complete, total laparoscopic hysterectomy, for example,by, in part, positioning and inflating the balloon within the uterinecavity, capturing the vaginal fornix in the inner cap, and maintainingthe pneumoperitoneum by properly positioning the disc, a laparoscope canbe inserted through a surgically formed incision in the wall of thepatient's abdomen to allow for visualization of the peritoneal cavityand the uterus to assist with the hysterectomy. Other conventional formsof uterine manipulators and vaginal cervical retractors exist andcontain similar features.

However, some conventional uterine manipulators and vaginal cervicalretractors do not include a mechanism or structural configuration tosufficiently maintain the cervical cup on the inner or manipulator tubeduring a particular medical procedure (as described above).Additionally, some conventional uterine manipulators and vaginalcervical retractors do not include a configuration to sufficiently fitand retain the balloon on the proximal end of the inner or manipulatortube. Indeed, the balloon of such conventional uterine manipulators andvaginal cervical retractors often bunches up during assembly implicatingcertain potential safety concerns during the particular medicalprocedure.

Accordingly, there is a need in the art for improved devices and methodsfor manipulation of the uterus and cervix in surgical and diagnosticprocedures including a mechanism or structural configuration tosufficiently maintain the cervical cup on the inner or manipulator tube,and a structural configuration to sufficiently fit and retain theballoon on the proximal end of the inner or manipulator tube.

Description of the Related Art Section Disclaimer: To the extent thatspecific patents/publications/products are discussed above in thisBackground Section or elsewhere in this Application, these discussionsshould not be taken as an admission that the discussedpatents/publications/products are prior art for patent law purposes. Forexample, some or all of the discussed patents/publications/products maynot be sufficiently early in time, may not reflect subject matterdeveloped early enough in time and/or may not be sufficiently enablingso as to amount to prior art for patent law purposes. To the extent thatspecific patents/publications/products are discussed above in thisBackground Section and/or throughout the application, thedescriptions/disclosures of which are all hereby incorporated byreference into this document in their respective entirety(ies).

SUMMARY OF THE INVENTION

The present disclosure is directed to inventive devices and methods formanipulation of the uterus and cervix in surgical and diagnosticprocedures. Various embodiments and implementations herein are directedto a uterine manipulator device that includes a manipulator tube and acervical cup with a hole feature (preferably centralized) positioned atthe base of the cervical cup through which the manipulator tube ispositioned. The distal portion of the perimeter of the hole feature canbe (but does not need to be) chamfered (i.e., angled from a longitudinalaxis positioned through the hole) to aid in sliding the cup along theshaft of the manipulator tube. The proximal portion of the perimeter, onthe other hand, can be straight and not chamfered/angled from thelongitudinal axis to increase the retention force of the cup on themanipulator tube and to aid in preventing detachment of the cup from themanipulator tube. Other combinations of chamfering and not chamferingconfigurations are contemplated (as should be understood by a person ofordinary skill in the art in conjunction with a review of thisdisclosure). For example, the distal portion of the hole can bechamfered and the proximal portion can be straight/not angled, or eachof the distal portion and the proximal portion can be partiallychamfered (which may or may not be chamfered at an equal amount).

Other embodiments and implementations herein are directed to a devicethat includes a balloon that is tapered at its distal end (or angledaway from the longitudinal axis) to sufficiently fit over a portion of acup retention mechanism positioned on a proximal portion of themanipulator tube and to retain the balloon on the cup retentionmechanism.

A particular non-limiting goal of utilization of the embodiments andimplementations herein is to provide a device for manipulation of theuterus and injection of fluids or gases during laparoscopic proceduressuch as laparoscopic assisted vaginal hysterectomy (LAVH), totallaparoscopic hysterectomy (TLH), minilap, laparoscopic tubal occlusionor diagnostic laparoscopy (and other similar procedures as should beunderstood by a person of ordinary skill in the art in conjunction witha review of this disclosure), and for the maintenance of apneumoperitoneum by sealing the vagina during such procedures. In brief,the uterine manipulator device of an embodiment allows a medicalpractitioner to more easily access key surgical targets in the pelviccavity by creating clear visibility of surgical landmarks and superiormobility of the uterus maximizing safe operative margins from the pelvicwall. The device can be structured and/or configured to displace thecervix away from the ureters, displace the bladder anetriorially, definethe dissecting plane of a colpotomy, and prevent loss ofpneumoperitoneum during the colpotomy (as noted above). Applicant hasrecognized and appreciated that it would be beneficial for medicalpractitioners to be able to approach such procedures with a higherdegree of confidence in performing a consistent, predictable andrepeatable procedure.

Generally, in one aspect, a uterine manipulator device includes: anelongated cannulated tube comprising a proximal end and a distal end; acervical cup having a top proximal portion of a first diameter and abase distal portion of a second smaller diameter, wherein: the basedistal portion includes a hole formed therein having a perimeterincluding a distal end and a proximal end, and including a longitudinalaxis positioned therethrough; one of the proximal end of the perimeterand the distal end of the perimeter is angled away from the longitudinalaxis and the other of the proximal end of the perimeter and the distalend of the perimeter is in line with the longitudinal axis; and theelongated cannulated tube is positioned through the hole in the cervicalcup.

According to another aspect, a uterine manipulator device includes: anelongated cannulated tube comprising a proximal end and a distal end; acervical cup having a top proximal portion of a first diameter and abase distal portion of a second smaller diameter, wherein: the basedistal portion includes a hole formed therein having a perimeterincluding a distal end and a proximal end, and including a longitudinalaxis positioned therethrough; the elongated cannulated tube ispositioned through the hole in the cervical cup; a retention mechanismpositioned on the elongated cannulated tube proximally to the cervicalcup, wherein the retention mechanism is configured to prevent detachmentof the cervical cup from the manipulator tube; and an intrauterineballoon positioned on the proximal end of the elongated cannulated tubeand having a proximal end and a distal end, wherein the distal end ofthe intrauterine balloon is angled away from the longitudinal axis.

As used herein for purposes of the present disclosure, the terms“distal” and “proximal” are used to describe locations of embodiments ofthe device from the perspective of a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and appreciated byreading the following Detailed Description in conjunction with theaccompanying drawings. The accompanying drawings illustrate only typicalembodiments of the disclosed subject matter and are therefore not to beconsidered limiting of its scope, for the disclosed subject matter mayadmit to other equally effective embodiments.

Reference is now made briefly to the accompanying drawings, in which:

FIG. 1 is a schematic representation of a uterine manipulator deviceaccording to an embodiment.

FIG. 2A is a schematic representation of the proximal end of the uterinemanipulator device according to an embodiment.

FIG. 2B is a schematic representation of the cervical cup of the uterinemanipulator device taken along A-A of FIG. 1 according to an embodiment.

FIG. 3A is a schematic representation of the proximal end of the uterinemanipulator device according to an embodiment.

FIG. 3B is a schematic representation of the intrauterine balloon of theuterine manipulator device taken along A-A of FIG. 3A according to anembodiment.

FIG. 4 is a schematic representation of the use of the uterinemanipulator device according to an embodiment.

Where applicable, like reference characters designate identical orcorresponding components and units throughout the several views, whichare not to scale unless otherwise indicated. Moreover, the embodimentsdisclosed herein may include elements that appear in one or more of theseveral views or in combinations of the several views.

DETAILED DESCRIPTION OF EMBODIMENTS

Referring to FIG. 1, in one embodiment, is a schematic representation ofa uterine manipulator device 100. The uterine manipulator device 100 caninclude (from the distal end 1 to the proximal end 3) a handle 5, a dyeinjection port 7 positioned in the handle 5 (preferably through thedistal end, and communicatively coupled to the intrauterine balloon 25),an inflation valve 9 (communicatively coupled to the intrauterineballoon 25), to which a syringe (e.g., 10 cc syringe, not shown) can beattached, and a pilot balloon 11 are attached to the handle 5(preferably through the proximal end), and a cannulated manipulator tube13. The cannulated manipulator tube 13 is curved at its proximal end andis straight at its distal end for easy introduction of the device 100,for manipulation of both retroverted and anteverted uteri, and formaintaining proper attitude of the uterus at the distal end. Thecannulated manipulator tube 13 is connected to the handle 5 (preferablyat the proximal end of the handle 5) and to the dye injection port 1,inflation valve 9, and pilot balloon 11 through the handle 5. Themanipulator tube 13 is configured to anatomically conform to the angleof the sacral curve, and to allow for easy manipulation of the uterus.The manipulator tube 13 can be marked with reference graduations (notshown) from the proximal end 3. The graduations can be provided as aguide for comparison to a graduated uterine sound, and can aid inattaining proper depth of insertion during use. The handle 5, which canprovide for the positioning of all four fingers on one side and thethumb on the opposite side (which can include a gripping/non-smoothsurface such as a plurality of raised portions or other non-smoothsurface structure as should be appreciated by a person of skill in theart in conjunction with a review of this disclosure), allows for easymanipulation of the uterus up, down and sideways.

The uterine manipulator device 100 incorporates a system of cup-likeelevators positioned on the manipulator tube 13 (which is positionedthrough a hole formed at the base of each cup) to provide manipulationof the uterus, and retraction and elevation of the cervix. Thesecup-like elevators can include a vaginal cup 19 and a cervical cup 23.The vaginal cup 19 tapers from a top distal portion with a firstdiameter to a base proximal portion with a second smaller diameter andcan include a cylindrical/tubular tail 21 positioned on the outside ofthe manipulator tube 13. A locking assembly is positioned distally tothe tubular tail 21 and includes a cylindrical portion 17 and athumbscrew 15. The cervical cup 23 is positioned on the proximal end ofthe manipulator tube 13, and can include sites/holes for suturingpositioned through the side of the cervical cup 23. The cervical cup caninclude various volumes and diameters, examples of which are shown inTable 1 below:

TABLE 1 Cervical Cup Cervical Cup Cervical Cup Volume DiameterDesignation  9.7 cm³ (0.59 in³) 32 mm (1.26 in) S 14.3 cm³ (0.87 in³) 34mm (1.34 in) M 20.7 cm³ (1.26 in³) 37 mm (1.46 in) L 26.7 cm³ (1.63 in³)40 mm (1.57 in) XL

An intrauterine balloon 25 is also shown, and is positioned on the mostproximal portion of the manipulator tube 13. The balloon (e.g., 10 ccinflatable balloon) is configured and positioned to reduce the risk ofuterine perforation and is used to stabilize the manipulator tube 13within the uterine cavity 303 (see FIG. 4) during use.

Turning to FIG. 2A, in one embodiment, is a schematic representation ofthe proximal end 3 of the uterine manipulator device 100. The vaginalcup 19 and cervical cup 23 have been removed to show the retentionmechanism for the cervical cup 23 positioned on the manipulator tube 13,which includes a retention ring 27 flanked by thermally fused heatshrink tubular portions 29 and 31 (which are configured to hold theretention ring in place on the manipulator tube 13). In brief, theretention ring 27, in conjunction with the heat shrink portions 29 and31, is positioned on the manipulator tube 13 and configured to preventdetachment of the cervical cup 23 from the manipulator tube 13. Theintrauterine balloon 25 has also been removed from FIG. 2, and theproximal portion of the manipulator tube 13 exposed by the removal ofthe intrauterine balloon 25 includes an opening with a proximal end of atube 33 connected to the inflation valve 9 and pilot balloon 11 forinflating the intrauterine balloon 25, and to the dye injection port 7.

Referring to FIG. 2B, in one embodiment, is a schematic representationof the cervical cup 23 taken along A-A of FIG. 1. As shown, the cervicalcup 23 tapers from a top proximal portion with a first diameter to abase distal portion with a second smaller diameter including a centralhole 37 having a perimeter 35. The perimeter is chamfered/angled awayfrom the longitudinal axis A at the distal end 35B, and is straight/notangled with respect to the longitudinal axis A at the proximal end 35A.The chamfering of the perimeter aids in the movement of the cervical cup23 along the manipulator tube 13. The straight/not angled perimeterportion aids in increasing the retention force of the cervical cup 23 onthe manipulator tube 13 and in preventing detachment of the cup from themanipulator tube 13. Additionally, the hole 37 diameter was decreased(from 2.15 cm to 2.05 cm). The combination of the straight/not angledperimeter portion and the narrowing of the diameter of the hole 37significantly increased the retention force of the cervical cup 23 onthe manipulator tube 13.

Turning to FIG. 3A, in one embodiment, is a schematic representation ofthe proximal end 3 of the uterine manipulator device 100. The vaginalcup 19 and cervical cup 23 have been removed. The intrauterine balloon25 is shown with a proximal end 25A positioned over the proximal end 3of the device 100, and a distal end 25B positioned over the retentionmechanism.

Referring to FIG. 3B, in one embodiment, is a schematic representationof the intrauterine balloon 25 taken along A-A of FIG. 3A. As shown, thedistal end 25B of the intrauterine balloon 25 is angled a certain amount(e.g., three degrees total) from the longitudinal axis to sufficientlyfit over a portion of the retention mechanism and to retain theintrauterine balloon 25 on the cup retention mechanism. Such a structureand configuration of the distal end 25B of the intrauterine balloon 25assists with a proper and clean assembly (no “bunching”) of theintrauterine balloon 25 on the device 100.

Referring to FIG. 4, in one embodiment, is a schematic representation ofthe use of the uterine manipulator device 100. The uterine manipulatordevice 100 is shown positioned through the vagina 305 with theintrauterine balloon 25 in the uterine cavity 303 and the vaginal fornix301 positioned within the cervical cup 23. After the intrauterineballoon 25 is positioned within the uterine cavity 303, a syringe isattached to the inflation valve 9 to inflate the intrauterine balloon 25(with, e.g. 7 cc of air and up to, e.g., 10 cc of air). The syringe isthen removed to prevent spontaneous deflation of the intrauterineballoon 25 by backward pressure. The cervical cup 23 is then slidproximally along the manipulator tube 13 until its outer edges surroundthe vaginal fornix 301 (as shown). The cervical cup 23 can optionally besutured in place. The vaginal cup 19 is then slid proximally along themanipulator tube 13 until it meets the distal edge of the cervical cup23 and is completely seated against the vaginal 305 walls and isconfigured, structured and/or positioned to ensure maintenance ofpneumoperitoneum as needed. The locking assembly is slid proximally tomeet the cylindrical/tubular tail 21 of the vaginal cup 19 and securedin place by turning the thumbscrew until it is tight. Manipulation ofthe uterus can then be carried out as may be necessary based on theparticular procedure (as should be understood by a person of ordinaryskill in the art in conjunction with a review of this disclosure), andvarious devices including visualization and other surgical devices (200,201) can be inserted through incisions made in the abdomen of thepatient.

While embodiments of the present invention has been particularly shownand described with reference to certain exemplary 8 embodiments, it willbe understood by one skilled in the art that various changes in detailmay be effected therein without departing from the spirit and scope ofthe invention as defined by claims that can be supported by the writtendescription and drawings. Further, where exemplary embodiments aredescribed with reference to a certain number of elements it will beunderstood that the exemplary embodiments can be practiced utilizingeither less than or more than the certain number of elements.

What is claimed is:
 1. A uterine manipulator device comprising: anelongated cannulated manipulator tube comprising a proximal end and adistal end; a cervical cup having a top proximal portion of a firstdiameter and a base distal portion of a second smaller diameter,wherein: the base distal portion includes a hole formed therein having aperimeter including a distal end and a proximal end, and including alongitudinal axis positioned therethrough; and the elongated cannulatedmanipulator tube is positioned through the hole in the cervical cup,wherein the uterine manipulator device further comprises a retentionmechanism comprising a retention ring positioned on the elongatedcannulated manipulator tube proximally to the cervical cup, wherein theretention ring is configured to prevent detachment of the cervical cupfrom the manipulator tube.
 2. The device of claim 1, wherein theproximal end of the elongated cannulated manipulator tube is nonlinear.3. The device of claim 1, further comprising a vaginal cup positioneddistally from the cervical cup on the elongated cannulated manipulatortube, wherein the vaginal cup includes a top distal portion with a firstdiameter and a base proximal portion with a second smaller diameter, andwherein the vaginal cup is configured to maintain pneumoperitoneumduring use.
 4. The device of claim 3, further comprising a lockingassembly positioned distally from the vaginal cup configured to lock thecervical cup and vaginal cup in place during use.
 5. The device of claim1, wherein one of the proximal end of the perimeter and the distal endof the perimeter is angled away from the longitudinal axis and the otherof the proximal end of the perimeter and the distal end of the perimeteris in line with the longitudinal axis.
 6. The device of claim 5, whereinthe retention mechanism further comprises a ring of heat shrinkpositioned on the elongated cannulated manipulator tube adjacent to theretention ring.
 7. The device of claim 6, further comprising anintrauterine balloon positioned on the proximal end of the elongatedcannulated manipulator tube and having a proximal end and a distal end.8. The device of claim 7, wherein the distal end of the intrauterineballoon is angled away from the longitudinal axis.
 9. The device ofclaim 8, further comprising a handle positioned on the distal end of theelongated cannulated manipulator tube.
 10. The device of claim 9,further comprising an inflation valve positioned through the handle andcommunicatively coupled to the intrauterine balloon.
 11. The device ofclaim 9, further comprising a dye injection port positioned through thehandle and communicatively coupled to the intrauterine balloon.
 12. Auterine manipulator device comprising: an elongated cannulatedmanipulator tube comprising a proximal end and a distal end; a cervicalcup having a top proximal portion of a first diameter and a base distalportion of a second smaller diameter, wherein: the base distal portionincludes a hole formed therein having a perimeter including a distal endand a proximal end, and including a longitudinal axis positionedtherethrough; the elongated cannulated manipulator tube is positionedthrough the hole in the cervical cup; a retention mechanism positionedon the elongated cannulated manipulator tube proximally to the cervicalcup, wherein the retention mechanism is configured to prevent detachmentof the cervical cup from the manipulator tube; and an intrauterineballoon positioned on the proximal end of the elongated cannulatedmanipulator tube and having a proximal end and a distal end, wherein thedistal end of the intrauterine balloon is angled away from thelongitudinal axis.
 13. The device of claim 12, wherein one of theproximal end of the perimeter and the distal end of the perimeter isangled away from the longitudinal axis and the other of the proximal endof the perimeter and the distal end of the perimeter is in line with thelongitudinal axis.
 14. The device of claim 12, wherein the proximal endof the elongated cannulated manipulator tube is nonlinear.
 15. Thedevice of claim 12, further comprising a vaginal cup positioned distallyfrom the cervical cup on the elongated cannulated manipulator tube,wherein the vaginal cup includes a top distal portion with a firstdiameter and a base proximal portion with a second smaller diameter, andwherein the vaginal cup is configured to maintain pneumoperitoneumduring use.
 16. The device of claim 15, further comprising a lockingassembly positioned distally from the vaginal cup configured to lock thecervical cup and vaginal cup in place during use.
 17. The device ofclaim 12, wherein the retention mechanism comprises a retention ring.18. The device of claim 17, wherein the retention mechanism furthercomprises a ring of heat shrink positioned on the elongated cannulatedmanipulator tube adjacent to the retention ring.
 19. The device of claim12, further comprising a handle positioned on the distal end of theelongated cannulated manipulator tube.
 20. The device of claim 19,further comprising an inflation valve positioned through the handle andcommunicatively coupled to the intrauterine balloon.